NPS Pharma (NPSP) announced encouraging additional data on its pipeline candidate Natpara (rhPTH [1-84]) from a phase III study (:REPLACE). The 24-week international study evaluated patients suffering from hypoparathyroidism, a rare endocrine disorder. Results from the study revealed that treatment with the candidate had a favorable impact on bone health of the patients.
The phase III study involved the progressive reduction of active vitamin D and calcium, while Natpara could be titrated up from 50 to 75/ 100 µg. Data revealed that treatment with Natpara (50, 75 or 100µg/day subcutaneous injection) caused an improvement of bone remodeling. This was witnessed by an increase in bone turnover markers and the reduction in bone mineral density. However, similar improvements were not witnessed in patients treated with only calcium and active vitamin D.
Moreover, results were also presented from the PARADOX research (n=374). The research examined the clinical, social and economic implications of hypoparathyroidism in adults diagnosed at least six months ago. Results revealed that patients suffer from illnesses related to the skeleton and joints. Moreover, they experienced bone-related symptoms and comorbidities even after being treated with calcium and active vitamin D.
The company expects to submit a Biologic License Application to the U.S. Food and Drug Administration (:FDA)) for Natpara by year end. NPS Pharma expects the drug to be approved in the U.S. before 2014 ends.
Gattex is NPS Pharma’s sole marketed product. NPS Pharma launched Gattex in the U.S. in Feb 2013, following approval by the FDA in Dec 2012. The drug was cleared for treating adults with short bowel syndrome, dependent on parenteral support. The drug was cleared in the EU in 2012 (European trade name: Revestive). The company expects to launch the drug in the EU in the first half of 2014. NPS Pharma expects peak sales of the drug to be higher in international markets than in the U.S.
NPS Pharma carries a Zacks Rank #3 (Hold). Currently, companies which look attractive include Actelion Ltd. (ALIOF), Isis Pharmaceuticals, Inc. (ISIS) and Alexion Pharmaceuticals, Inc. (ALXN). Actelion and Isis carry a Zacks Rank #1 (Strong Buy), while Alexion is a Zacks #2 Ranked (Buy) stock.